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510(k) K181038

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) by Cormatrix Cardiovascular, Inc. — Product Code PSQ

K181038 is an FDA 510(k) premarket notification submitted by Cormatrix Cardiovascular, Inc. for the device "CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)". The FDA issued a decision of Substantially Equivalent on October 10, 2018. The device falls under product code PSQ (Intracardiac Patch Or Pledget, Biologically Derived), a Class II device regulated under 21 CFR 870.3470. Cormatrix Cardiovascular, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2018
Date Received
April 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intracardiac Patch Or Pledget, Biologically Derived
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

Other clearances by Cormatrix Cardiovascular, Inc.

  • K152127 — CorMatrix Tyke (February 4, 2016)
  • K140306 — CORMATRIX PROTECT ECM ENVELOPE (August 15, 2014)
  • K140789 — CORMATRIX ECM FOR VASCULAR REPAIR (July 15, 2014)
  • K111187 — PATCH, PLEDGET AND INTRACARDIAC (July 26, 2011)
  • K063349 — CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR (February 16, 2007)
  • K051405 — REGENSIS PERICARDIAL PATCH (August 31, 2005)

Other clearances for product code PSQ

  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K210331 — CardiaMend Pericardial and Epicardial Reconstruction Matrix (December 21, 2021)
  • K200566 — ADAPT Tissue (April 3, 2020)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K191734 — MatriStem UBM Pericardial Patch (November 22, 2019)
  • K183635 — PhotoFix Decellularized Bovine Pericardium (February 14, 2019)
  • K172085 — PhotoFix Decellularized Bovine Pericardium (December 4, 2017)
  • K172660 — Duravess bovine pericardial vascular patch (November 17, 2017)
  • K170951 — CardioCel 3D (April 28, 2017)

FDA data resources